The EU Commission has updated the results of the Study Supporting the Monitoring of the Availability of Medical Devices on the EU market. This new update is concerning a period ending in December 2025. The results have been documented in a .pdf power point which is split up into 5 sections: To offer some background … Read more
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a questionnaire to gather feedback on the anticipated impacts of the Medical Devices (Amendment) Regulations 2026. The questionnaire is intended to collect information on the costs and benefits associated with the proposed regulations, which aim to strengthen safe access to medical devices and in vitro … Read more
We are pleased to announce that Advena will be exhibiting at MedTech Expo NEC 2026 in June. The fair will be held on the 3rd to 4th June at the National Exhibition Centre (NEC), Birmingham in the UK. Representing Advena at the event will be our CEO & Managing Director Anthony Kirby and our Regulatory … Read more
As the EU regulatory framework for medical devices and in vitro diagnostic devices continues to mature, May 2026 marks a critical milestone for manufacturers operating under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Several high-priority deadlines will take effect during this month, requiring immediate attention to ensure ongoing … Read more
We’re pleased to announce that this edition of the newsletter as well as future editions will also be available in a video summary format, offering a convenient way to catch up on the latest regulatory updates. To watch the full video summary for the month of April, please click on video below.
Medical device classification in the EU follows a risk-based approach, considering factors such as invasiveness, duration of contact, and potential impact on the body. These criteria, set out in Annex VIII of the MDR, guide manufacturers in assigning the correct class, which in turn determines the level of regulatory scrutiny and conformity assessment required. The … Read more
The Borderline Manual on Medical Devices has recently been updated, introducing five additional product examples that fall into “grey areas” of qualification and classification. Originally published in 2022, this guidance aims to support manufacturers in determining whether a product qualifies as a medical device and how it should be classified under the MDR. 1. Device … Read more
The European Commission has updated its Q&A on the information obligations related to the interruption or discontinuation of supply of certain medical devices and in vitro diagnostic devices (IVDs). By way of background, Regulation (EU) 2024/1860—adopted in 2024—introduced several amendments aimed at strengthening patient safety and improving regulatory efficiency. Key developments include the gradual roll-out … Read more
The European Commission has published Implementing Decision (EU) 2026/760, further updating the list of harmonized standards supporting compliance with the Medical Devices Regulation (EU) 2017/745 (MDR). In particular, the Decision adds three new harmonized standards: Implementing Decision (EU) 2026/760 can be accessed using the following link
ISO 20417:2026 has been published, setting out updated general requirements for the information to be supplied by manufacturers of medical devices and their accessories. The standard covers key elements such as device identification, labelling, packaging information, marking, and accompanying documentation, including instructions for use. ISO 20417 continues to serve as a foundational framework, establishing common … Read more
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